1.Field of the Invention
The present invention relates to an analgesic composition useful for preparing fast dissolving tablets containing ibuprofen and arginine and the tablets made therefrom.
2.Discussion of the Background
Ibuprofen is the International common name of the compound 2-(4-isobutylphenyl)-propionic acid, which is a known drug with analgesic, as well as anti-inflammatory and antipyretic, activity of broad diffusion.
In U.S. Pat. No. 4,279,926, ibuprofen salts with basic amino acids such as arginine and lysine have been described.
In U.S. Pat. No. 4,689,218 effervescent compositions of ibuprofen containing arginine together with 20-30% by weight of bicarbonate and 25-40% by weight of sodium bitartrate have been described.
The described formulations are useful for preparing drinkable aqueous solutions.
In U.S. Pat. No. 4,834,966 non-effervescent compositions are disclosed consisting, as a base, of a ternary mixture consisting of ibuprofen, 1.1 to 1.5 mol% arginine per mole of ibuprofen and sodium bicarbonate in a weight amount between 0.25 and 0.75 times the weight of ibuprofen.
These formulations are disclosed as very suitable for the preparation of granulates quickly soluble in water.
The administration of the so obtained aqueous solutions assures a fast analgesic effect which is achieved in about ten minutes.
Sachets containing the granulate of U.S. Pat. No. 4,834,966 are on the market. In some countries, and in particular in the U.S.A., preparations in the form of a sachet are not particularly appreciated by the public, who generally prefer the use of tablets in the treatment of conditions which need an analgesic drug.
The commercially available tablets containing ibuprofen do not have a particularly fast effect because they require about 30 minutes to completely dissolve and reach the blood stream.
In order to obtain a quick dissolution of the active principle, the present inventors tried preparing tablets starting from the ibuprofen-arginine-sodium bicarbonate ternary mixture of the above mentioned U.S. Pat. No. 4,834,966.
Unfortunately, it was impossible to obtain satisfactory results because the resulting tablets were too friable and subject to fragmentation during manufacturing and packaging.